MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS 3M ESPE RELYX LUTING PLUS CEMENT; DENTAL CEMENT

Catalog Number 3525TK

Device Problems Hole In Material (1293); Material Perforation (2205)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Upon 3m follow-up with the patient's pediatric dentist who placed the stainless steel crown, a perforation of a stainless steel crown is not unusual, especially after almost three years, and could be caused by the masticatory function of the child or bruxism.However, it should be noted that 3m has not received any similar complaints of this nature in the past.This event involved two 3m products; therefore, two manufacturer reports are being submitted.This report represents the second product.Manufacturer report 3005174370-2017-00044 represents the second product.

Event Description

On (b)(6) 2017, 3m was notified that an (b)(6) year-old male patient required a tooth extraction due to tooth decay which was noted after a 3m stainless steel crown fell off his tooth.The stainless steel crown was reported to have a hole in the center surface.The crown was originally placed in (b)(6)2014 using 3m espe relyx luting plus cement.

• Brand Name: 3M ESPE RELYX LUTING PLUS CEMENT
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; 2510 conway avenue; st. paul MN 55144 1000
• Manufacturer (Section G): 3M ESPE DENTAL PRODUCTS; 2510 conway avenue; st. paul MN 55144 1000
• Manufacturer Contact: angie draper ; 2510 conway avenue; st. paul, MN 55144-1000 ; 6517331179
• MDR Report Key: 6786846
• MDR Text Key: 82458035
• Report Number: 3005174370-2017-00045
• Device Sequence Number: 1
• Product Code: EMA
• UDI-Device Identifier: 30605861013476
• UDI-Public: 30605861013476
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K022476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 3525TK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2017
• Initial Date FDA Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR